Medication info

Itracon Capsules (Itraconazole)

Prescription medicationExpired
Ingredient · strength
Itraconazole›Strength being verified
Manufacturer / importer
International Pharmaceutical Co., Ltd.
Appearance
Hard capsules with a white to pale yellow granule filling in the upper part and a light pink lower part.
Packaging
28 capsules/bottle, 30 capsules/bottle
Approval status
Expired

MFDS item code 200500385 · Approved 2005.01.06

This product's status changed to Expired on 2023.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of fungal infections of the skin and nails, fungal infections of the mucosa and cornea, and treatment and prevention of systemic fungal infections
Who uses it
Adults · Children
Adult dosage
(Tablets)(Capsules) To increase absorption, this medicine should preferably be taken immediately after a meal. 1. Short-term treatment This medicine continues to have a therapeutic effect in skin tissue even after discontinuation. Therefore, the final clinical and mycological response should preferably be assessed 2~4 weeks after completion of the prescribed treatment. 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. 2) Pityriasis versicolor: Administer 200 mg once daily for 7 days. 3) Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital type), tinea pedis (interdigital type): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palms), tinea pedis (soles): Administer 100 mg once daily for 30 days, or 200 mg twice daily for 7 days. 6) Oropharyngeal candidiasis: Administer 100 mg once daily for 15 days. 7) Fungal keratitis: Administer 200 mg once daily for 21 days. 2. Onychomycosis 1) Pulse therapy Administer 200 mg twice daily for 1 week, followed by 3 weeks without treatment; this constitutes one cycle. Administer up to 2 cycles for infection limited to the fingernails, and up to 3 cycles for infection of the toenails. Site of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without concurrent fingernail infection) Treatment No treatment Treatment No treatment Treatment Fingernails Treatment No treatment Treatment Or 2) Continuous therapy Administer 200 mg once daily for 3 months. The therapeutic effect continues for 3 months for fingernails and 6 months for toenails after the end of treatment. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients, oral bioavailability of this medicine may be reduced; if necessary, double the dose. Aspergillosis: 200mg once daily; average treatment duration 2~5 months. For invasive or disseminated disease, increase to 200mg twice daily. Candidiasis: 100~200mg once daily; average treatment duration 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily; average treatment duration 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily; average treatment duration 6 months. (Oral solution) To increase absorption, do not take this medicine with food. Hold this medicine in the mouth for approximately 20 seconds, allowing it to contact the entire oral cavity, then swallow. After swallowing, do not rinse the mouth so that the medicine remains in contact for as long as possible. 1. Oral and esophageal candidiasis Take 200 mg (20 mL) per day in 1~2 divided doses for 1 week. If there is no response after 1 week, continue for 1 additional week. 2. Fluconazole-resistant oral and esophageal candidiasis Take 200~400 mg (20~40 mL) per day in 1~2 divided doses for 2 weeks. If there is no response after 2 weeks, continue for 2 additional weeks. Even if symptoms do not improve, do not use 400 mg per day for more than 14 days.
Children's dosage
Administer 5 mg/kg of body weight per day in 2 divided doses.

Ingredients

Manufacturer
International Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of fungal infections of the skin and nails, fungal infections of the mucosa and cornea, and treatment and prevention of systemic fungal infections

  • Candidal vulvovaginitis
  • tinea versicolor
  • tinea corporis
  • tinea capitis
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
  • paracoccidioidomycosis
View approved original text

This medication is used to treat various fungal infections. It is effective against dermatophyte infections such as candidal vulvovaginitis, tinea versicolor, tinea corporis, tinea capitis, tinea pedis, as well as oral candidiasis, fungal keratitis, and onychomycosis. It is also used for severe systemic fungal infections including aspergillosis, candidiasis, cryptococcosis including meningitis, and paracoccidioidomycosis. The liquid formulation is suitable for the treatment of oral and esophageal candidiasis in patients with HIV infection or those who are immunocompromised, and for the prevention of systemic fungal infections in patients with blood malignancies or those undergoing bone marrow transplants. However, clinical data on the prevention of aspergillosis is insufficient, so this should be noted. This drug is used effectively for the treatment and prevention of fungal infections.

Dosage and Administration

Adult dosage

(Tablets)(Capsules) To increase absorption, this medicine should preferably be taken immediately after a meal. 1. Short-term treatment This medicine continues to have a therapeutic effect in skin tissue even after discontinuation. Therefore, the final clinical and mycological response should preferably be assessed 2~4 weeks after completion of the prescribed treatment. 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. 2) Pityriasis versicolor: Administer 200 mg once daily for 7 days. 3) Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital type), tinea pedis (interdigital type): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palms), tinea pedis (soles): Administer 100 mg once daily for 30 days, or 200 mg twice daily for 7 days. 6) Oropharyngeal candidiasis: Administer 100 mg once daily for 15 days. 7) Fungal keratitis: Administer 200 mg once daily for 21 days. 2. Onychomycosis 1) Pulse therapy Administer 200 mg twice daily for 1 week, followed by 3 weeks without treatment; this constitutes one cycle. Administer up to 2 cycles for infection limited to the fingernails, and up to 3 cycles for infection of the toenails. Site of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without concurrent fingernail infection) Treatment No treatment Treatment No treatment Treatment Fingernails Treatment No treatment Treatment Or 2) Continuous therapy Administer 200 mg once daily for 3 months. The therapeutic effect continues for 3 months for fingernails and 6 months for toenails after the end of treatment. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients, oral bioavailability of this medicine may be reduced; if necessary, double the dose. Aspergillosis: 200mg once daily; average treatment duration 2~5 months. For invasive or disseminated disease, increase to 200mg twice daily. Candidiasis: 100~200mg once daily; average treatment duration 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily; average treatment duration 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily; average treatment duration 6 months. (Oral solution) To increase absorption, do not take this medicine with food. Hold this medicine in the mouth for approximately 20 seconds, allowing it to contact the entire oral cavity, then swallow. After swallowing, do not rinse the mouth so that the medicine remains in contact for as long as possible. 1. Oral and esophageal candidiasis Take 200 mg (20 mL) per day in 1~2 divided doses for 1 week. If there is no response after 1 week, continue for 1 additional week. 2. Fluconazole-resistant oral and esophageal candidiasis Take 200~400 mg (20~40 mL) per day in 1~2 divided doses for 2 weeks. If there is no response after 2 weeks, continue for 2 additional weeks. Even if symptoms do not improve, do not use 400 mg per day for more than 14 days.

Children's dosage

Administer 5 mg/kg of body weight per day in 2 divided doses.

Precautions

This medication is not recommended for patients with impaired heart function or those with a history of heart failure. If symptoms of heart failure occur during treatment, the medication should be discontinued immediately. Patients with a history of allergy to this drug or its components should not take this medication. Additionally, severe side effects may occur when taken with certain medications, so any concurrent medications should be discussed with a doctor or pharmacist. Women who are pregnant, potentially pregnant, or breastfeeding should not take this medication due to its possible effects on the fetus and transfer through breast milk to the baby. Patients with impaired liver or kidney function should take this medication with caution and undergo regular liver function tests. Immunocompromised patients or those with specific neurological disorders should also use this medication cautiously. Dizziness, visual disturbances, and hearing loss may occur while taking this medication, so caution is needed when driving or operating machinery. This medication has numerous drug interactions, so any other medications being taken should be reported to healthcare providers, and it should not be used with contraindicated medications. In case of overdose, as there is no specific antidote, symptoms should be evaluated, and appropriate treatment sought immediately. Lastly, this medication should be kept out of reach of children and stored in its original container to prevent misuse or degradation of quality.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory disturbance, dysesthesia, tinnitus, constipation, diarrhea, dyspepsia, abdominal distension, vomiting, abnormal liver function, hyperbilirubinemia, itching, rash, urticaria, frequent urination, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reactions, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorder, cough, gastrointestinal disturbances, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reactions, double vision, transient or permanent hearing loss, ventricular extrasystoles, atrioventricular block, palpitations, increased bowel activity, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, elevated serum total protein, elevated total bilirubin, increased LAP, loss of appetite, malaise, brown urine, increased liver enzyme levels, mucous membrane injury syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Reiter's syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein test, positive urine glucose test, decreased libido, drowsiness, shoulder pain, insomnia, chest pain, elevated serum triglycerides, flushing, elevated serum uric acid, elevated serum potassium levels, serum sickness, angioedema, anaphylactic reactions, hypertriglyceridemia, tremor, visual impairment, congestive heart failure, dyspnea, significant hepatotoxicity, toxic epidermal necrolysis, Steven-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase activity

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to prevent air and moisture from entering, preferably at room temperature between 1°C and 30°C. Proper storage helps maintain the drug's effectiveness and prevents degradation.

Appearance and packaging

Appearance

Hard capsules with a white to pale yellow granule filling in the upper part and a light pink lower part.

Package unit

28 capsules/bottle, 30 capsules/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.